Business · 07/11/2002
FDA Classifies Transcutaneous Air Conduction Hearing Aid System into Class II Special Controls
The FDA is classifying the transcutaneous air conduction hearing aid system into Class II special controls to ensure the device's safety and effectiveness, following a petition submitted under the Federal Food, Drug, and Cosmetic Act and other medical device amendments.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →